STIM: Stimulation to Improve Memory

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT03875326
Collaborator
National Institute on Aging (NIA) (NIH)
240
1
4
66
3.6

Study Details

Study Description

Brief Summary

This study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (MCI) and dementia of the Alzheimer's Type (DAT).

Condition or Disease Intervention/Treatment Phase
  • Device: 1 mA HD-tDCS
  • Device: 2 mA HD-tDCS
  • Device: 3 mA HD-tDCS
  • Device: Sham
N/A

Detailed Description

This research study is being done to learn important information about the effects of weak electrical stimulation on brain functioning in those with mild cognitive impairment (MCI) and dementia of the Alzheimer's type (DAT). The findings will help determine "how much" stimulation is needed to enhance memory and thinking abilities, how it affects brain functioning, and who is most likely to benefit. Ultimately, this information may guide treatment efforts for those at various stages of Alzheimer's disease. The study will use brain imaging to see whether these treatments change how participants learn and remember information. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) scans will be used. The study will also use cognitive tests and questionnaires to examine whether participants' memory (and related abilities) change because of treatment. The study will enroll participants with a diagnosis of MCI or DAT. It is expected but not required that participants will be co-enrolled in the University of Michigan Memory and Aging Project (UM-MAP; HUM00000382).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Eligible participants will be randomized 1:1:1:1 to receive either sham, 1mA, 2mA, or 3mA HD-tDCS for at least 5 sessions and up to 30 sessions using a blocked randomization design.Eligible participants will be randomized 1:1:1:1 to receive either sham, 1mA, 2mA, or 3mA HD-tDCS for at least 5 sessions and up to 30 sessions using a blocked randomization design.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) as Treatment of Mild Cognitive Impairment
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham Stimulation

Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Device: Sham
Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.

Experimental: 1 mA Dosage Stimulation

1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Device: 1 mA HD-tDCS
Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.

Experimental: 2 mA Dosage Stimulation

2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Device: 2 mA HD-tDCS
Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.

Experimental: 3 mA Dosage Stimulation

3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Device: 3 mA HD-tDCS
Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.

Outcome Measures

Primary Outcome Measures

  1. Change in Lateral Temporal Cortex Connectivity [Baseline fMRI and post-intervention (after tDCS sessions 5 & 30)]

    Graph Theory Analysis via fMRI using arbitrary units of connectivity strength

Secondary Outcome Measures

  1. Self-Report of Contentment with Memory [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Multifactorial Memory Questionnaire (MMQ) Contentment Score

  2. Self-Report of Memory Mistakes [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Multifactorial Memory Questionnaire (MMQ) Ability Score

  3. Self-Report of Memory Strategies Used [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Multifactorial Memory Questionnaire (MMQ) Strategies Score

  4. Change in Memory Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Measured through change in the RBANS Delayed Memory Index

  5. Change in Overall Fluid Cognitive Abilities [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Measured through change in the NIH Toolbox Cognition Fluid Composite Score

  6. Cumulative Working Memory Effects of HD-tDCS across daily sessions [Baseline Session through Session 6 then weekly up to final session]

    Working memory accuracy measured by a discriminability ratio (2-back d' minus 0-back d') on a validated computerized N-Back task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)

  7. Cumulative Memory Accuracy Effects of HD-tDCS across daily sessions [Baseline Session through Session 6 then weekly up to final session]

    Verbal memory accuracy measured by an accuracy score (percent correct) on a computerized Paired Associates task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)

  8. Cumulative Memory Reaction Time Effects of HD-tDCS across daily sessions [Baseline Session through Session 6 then weekly up to final session]

    Verbal memory reaction time measured by a drift rate score (V; measured by the mean rate at which information is accumulated towards a boundary [correct or error response]) on a computerized Paired Associates task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)

  9. Tolerability of HD-tDCS [Prior to and immediately following each HD-tDCS session (<60 Minutes)]

    Evaluated using standard questionnaires that arose from comprehensive reviews of the tDCS literature, this questionnaire was recently refined to include pre- and post-HD-tDCS symptom assessment. This will be administered prior to and immediately after every brain stimulation session (including sham).

  10. Effectiveness of Blinding of HD-tDCS [Immediately following HD-tDCS sessions 5 and final session (<60 Minutes)]

    Evaluated using a standard single question administered after every brain stimulation session (including sham).

Other Outcome Measures

  1. Change in Default Mode Network Connectivity [Baseline fMRI and post-intervention (after tDCS sessions 5 & 30)]

    Graph Theory Analysis via fMRI using arbitrary units of connectivity strength to measure changes in the Default Mode Network, along with strength in and between other networks

  2. Change in Inhibition Ability [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    A priori intent to measure through change in the NIH Toolbox Flanker Inhibitory Control and Attention Test Score

  3. Change in Conceptualization Ability [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    A priori intent to measure through change in the NIH Toolbox Dimensional Change Card Sort Test Score

  4. Change in Picture Sequence Memory [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    A priori intent to measure through change in the NIH Toolbox Picture Sequence Memory Test Score

  5. Change in Working Memory Ability [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    A priori intent to measure through change in the NIH Toolbox List Sorting Working Memory Test Score

  6. Change in Processing Speed [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    A priori intent to measure through change in the NIH Toolbox Pattern Comparison Processing Speed Test Score

  7. Cumulative Working Memory Performance Effects of HD-tDCS across daily sessions [Baseline Session through Session 6 then weekly up to final session]

    A priori intent to explore d' change for each N-Back task condition (2-back, 0-back) in order to understand the overall effect of the HD-tDCS on task performance.

  8. Change in Global Cognition [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Measured through change in the Total RBANS Score

  9. Change in Visuospatial Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Measured through change in the RBANS Visuospatial Index score

  10. Change in Language Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Measured through change in the RBANS Language Index score

  11. Change in Attention [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Measured through change in the RBANS Attention Index score

  12. Change in Memory Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    Measured through change in the RBANS Immediate Memory Index score

  13. Change in Cognitive Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]

    A priori intent to measure through changes in RBANS subtest scores

  14. Cumulative Cognitive Change across Daily Consecutive Sessions [After each HD-tDCS Session, daily]

    Measured through change in Cogstate or other comparable computerized cognitive testing scores across consecutive daily sessions

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Diagnosis of Mild Cognitive Impairment (MCI) or dementia of the Alzheimer's type (DAT)

  2. Must be MRI compatible, criteria that also apply for High Definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)

  3. Stable on relevant medications for at least 4 weeks prior to study enrollment

Exclusion Criteria:
  1. Certain neurological diseases

  2. Certain psychiatric conditions

  3. Severe sensory impairment

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48105

Sponsors and Collaborators

  • University of Michigan
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Benjamin Hampstead, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Benjamin Hampstead, PhD, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT03875326
Other Study ID Numbers:
  • HUM00146180
  • 1R01AG058724
First Posted:
Mar 14, 2019
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Benjamin Hampstead, PhD, Associate Professor, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2022